DEVICE: DUO+ 240 Treatment Head (B271DUO2400)

Device Identifier (DI) Information

DUO+ 240 Treatment Head
DUO+ 240
In Commercial Distribution

Meditech International Inc
B271DUO2400
HIBCC

1
255079485 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Red-light phototherapy unit, line-powered A mains electricity (AC-powered) device designed to emit a low-level narrow-band (LLNB) red light in the visible and invisible wavelength around 600-940 nm, with the intent to modify cellular metabolism and/or improve blood flow through increased vasodilation primarily for the accelerated healing of cutaneous or mucosal wounds and/or to provide pain relief. It can be used in a healthcare facility and in the home. It may be used to help treat skin ulcers, acne, herpes simplex lesions, and postoperative wounds, or to relieve pain associated with inflammatory processes such as rheumatoid arthritis (RA) or lower back injury.
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FDA Product Code

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Product Code Product Code Name
NHN Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
ILY Lamp, Infrared, Therapeutic Heating
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K023621 000
K051875 000
K072551 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

7a86046f-589a-4c0d-a35a-e968f7769251
July 06, 2018
3
August 09, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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Yes
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Customer Contact

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No Customer Contact currently defined
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